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Generic Name: pirfenidone (pir FEN i done)
Brand Names: Esbriet

What is Esbriet?

Esbriet (pirfenidone) is used to treat a lung disease called idiopathic pulmonary fibrosis(IPF). IPF causes scar tissue to form deep within your lungs. The scar tissue thickens and becomes stiff or thick over time, which can make it harder for your lungs to work. Decreased lung function can make it hard for you to breathe. Other medical problems can occur when your brain, heart, and other organs do not get enough oxygen.

The cause of IPF is often unknown, but this condition is a progressive disease that can be fatal. Esbriet is not a cure for IPF, but this medicine may slow the progress of this disease.

Esbriet may also be used for purposes not listed in this medication guide.

Important information

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Before taking this medicine

You should not use Esbriet if you are allergic to pirfenidone.

To make sure Esbriet is safe for you, tell your doctor if you have:

  • liver disease;

  • kidney disease;

  • a stomach disorder such as gastroesophageal reflux disease (GERD) or slow digestion; or

  • if you smoke.

FDA pregnancy category C. It is not known whether Esbriet will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

See also: Pregnancy and breastfeeding warnings (in more detail)

It is not known whether pirfenidone passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

How should I take Esbriet?

Take Esbriet exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Your doctor will perform blood tests to make sure you do not have conditions that would prevent you from safely using Esbriet.

Esbriet should be taken with food to help decrease nausea or dizziness.

Esbriet is usually taken 3 times per day. Your dose needs will change over the first 15 days of your treatment.

  • For the first week, you will take only 1 capsule at a time.

  • During the second week, you will take 2 capsules at a time.

  • From the third week on, you will take 3 capsules at a time.

You must follow this 2-week "dose escalation" schedule when you start taking Esbriet, or if you start taking the medicine again after not taking it for 14 days or longer. Follow your doctor's dosing instructions very carefully.

If you do stop taking this medicine for any reason, talk with your doctor before restarting the medicine.

You may need frequent medical tests to be sure Esbriet is not causing harmful effects on your liver. Your next few doses may be delayed or reduced based on the results of these tests.

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

Esbriet dosing information

Usual Adult Dose for Idiopathic Pulmonary Fibrosis:

Initial dose:
-Days 1 to 7: 267 mg (one capsule) orally three times a day
-Days 8 to 14: 534 mg (two capsules) orally three times a day
Maintenance/Maximum dose (Day 15 onward): 801 mg (three capsules) orally three times a day

-Take with food to reduce nausea and dizziness.
-Doses should be taken at the same time each day.

Use: Idiopathic pulmonary fibrosis (IPF)

See also: Dosage Information (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Do not take more than 3 doses in one day.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking Esbriet?

Avoid exposure to sunlight or tanning beds. Esbriet can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Avoid smoking while taking this medicine. Smoking could make Esbriet less effective.

Esbriet side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Esbriet: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using Esbriet and call your doctor at once if you have:

  • severe ongoing stomach pain, vomiting, diarrhea;

  • burning or pain in your esophagus or throat;

  • easy bruising or bleeding (nosebleeds, bleeding gums); or

  • liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common Esbriet side effects may include:

  • nausea, vomiting, loss of appetite;

  • stomach pain, heartburn, upset stomach;

  • diarrhea;

  • headache, dizziness, tired feeling;

  • weight loss;

  • cold symptoms such as stuffy nose, sneezing, sore throat;

  • sleep problems (insomnia);

  • joint pain; or

  • abnormal liver function tests.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

What other drugs will affect Esbriet?

Other drugs may interact with pirfenidone, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Where can I get more information?

  • Your pharmacist can provide more information about Esbriet.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Esbriet only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2016 Cerner Multum, Inc. Version: 1.01. Revision Date: 2014-12-10, 2:26:46 PM.